FDA Approves Loteprednol Gel for Eye Surgery Pain

Emma Hitt, PhD


October 02, 2012

October 2, 2012 — The US Food and Drug Administration (FDA) has approved the new drug application (NDA) for loteprednol etabonate ophthalmic gel, 0.5% (Lotemax, Bausch + Lomb) for the treatment of postoperative inflammation and pain after ocular surgery, according to an announcement from the manufacturer today.

Loteprednol etabonate, the active ingredient, was approved in 1998 as an ocular antiinflammatory agent. The agent is currently available from the company in 0.5% ointment and suspension forms.

The new formulation is applied in 1 or 2 drops to the conjunctival sac of the affected eye 4 times daily beginning the day after surgery and for the subsequent 2 weeks.

As with other ophthalmic corticosteroids, loteprednol etabonate ophthalmic gel, 0.5%, should not be used in patients with viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, or in those with mycobacterial infection of the eye and fungal diseases of ocular structures. This agent also increases the risk for glaucoma, cataracts, and other nonviral infections.

According to the manufacturer, the most common ocular adverse reactions reported in patients treated with loteprednol etabonate gel were anterior-chamber inflammation (5%), eye pain (2%), and foreign body sensation (2%).

"This is a safe but potent ester corticosteroid, delivered with a soothing long-lasting vehicle and decreased preservative concentration," said independent commentator John Sheppard, MD, from the Department of Ophthalmology at Eastern Virginia Medical School, Norfolk, Virginia. "This is an improvement in an already extremely useful product, applicable to both induction and peri-operative use as well as maintenance scenarios for chronic anterior segment and ocular surface conditions," he told Medscape Medical News.

According to Dr. Sheppard, the increased viscosity of the preparation means that the agent will last longer on the ocular surface. "This allows decreased dosage frequency for many of my patients, titrating of course to their individual needs," although he added that "some patients may have initial difficulty in placing the gel directly into the eye, especially if they have long lashes and blepharospasm."


"Gels are becoming more popular because of their enhanced pharmacokinetic profile. When administering serial medications, the more viscous should be placed last in the series after the solutions and suspensions," he said. "This allows for not only better ocular surface exposure of the less viscous agents, but also the potential for extended duration of the initially administered solutions and suspensions whose own pharmacokinetics may be extended by the overlying gel."

Dr. Sheppard states that he is a consultant and clinical researcher and speaker for Alcon, Allergan, Abbott, Bausch & Lomb, Lux, EyeGate, and Merck.